EMA Validates Bristol-Myers Squibb’s Variation Application for Opdivo Plus Yervoy Combination for Treatment of First-Line Metastatic Non-Small Cell Lung Cancer

Bristol-Myers Squibb Company (NYSE: BMY) announced on 5/3/18 that the European Medicines Agency (EMA) validated a type II variation application for the Opdivo (nivolumab) plus Yervoy(ipilimumab) combination for treatment in adult patients with first-line metastatic non-small cell lung cancer (NSCLC) who have tumor mutational burden (TMB) ≥10 mutations/megabase (mut/Mb). Validation of the application confirms the submission is complete and begins the EMA’s centralized review process.